Otrexup

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Otrexup

OVERDOSE

Leucovorin is indicated to diminish the toxicity and
counteract the effect of inadvertently administered overdosages of
methotrexate. Leucovorin administration should begin as promptly as possible.
As the time interval between methotrexate administration and leucovorin
initiation increases, the effectiveness of leucovorin in counteracting toxicity
decreases. Monitoring of the serum methotrexate concentration is essential in
determining the optimal dose and duration of treatment with leucovorin.

In cases of massive overdosage, hydration and urinary
alkalinization may be necessary to prevent the precipitation of methotrexate
and/or its metabolites in the renal tubules. Generally speaking, neither hemodialysis
nor peritoneal dialysis has been shown to improve methotrexate elimination.
However, effective clearance of methotrexate has been reported with acute,
intermittent hemodialysis using a high-flux dialyzer (Wall, SM et al: Am J
Kidney Dis 28 (6): 846-854, 1996).

There have been reports of death following overdose. In
these cases, events such as sepsis or septicshock, renal failure, and aplastic
anemia were also reported.

Symptoms of intrathecal overdose are generally central
nervous system (CNS) symptoms, including headache, nausea and vomiting, seizure
or convulsion, and acute toxic encephalopathy. In some cases, no symptoms were
reported. There have been reports of death following intrathecal overdose. In
these cases, cerebellar herniation associated with increased intracranial
pressure, and acute toxic encephalopathy have also been reported.

There are published case reports of intravenous and
intrathecal carboxypeptidase G2 treatment to hasten clearance of methotrexate in
cases of overdose.

CONTRAINDICATIONS

Otrexup is contraindicated in the following:

Pregnancy

Otrexup can cause fetal death or teratogenic effects when
administered to a pregnant woman.

Otrexup is contraindicated in pregnant women. If this
drug is used during pregnancy, or if the patient becomes pregnant while taking
this drug, the patient should be apprised of the potential hazard to the fetus [see
WARNINGS AND PRECAUTIONS and Use In Specific Populations].

Nursing Mothers

Because of the potential for serious adverse reactions
from methotrexate in breast fed infants, Otrexup is contraindicated in nursing
mothers [see Use In Specific Populations].